The goal of a registry is to enroll the highest possible number of patients in order to collect data. Patients who have a common attribute – e.g. are suffering from the same disease or receiving the same certain treatment – can become part of the registry. If the patients agree to participate, they give their…
Encyclopedia
Regulatory Affairs
Regulatory Affairs include all activities that predominantly deal with the regulations in the area of research, approval or marketing authorization. In pharmaceutical research, the Regulatory Affairs sector includes the application for approval / a positive opinion regarding the conduct of a clinical trial, the subsequent steps such as the reply to deficiency letters, notification of…